Hypothesis / aims of study
Recently, with the emergence of minimally invasive surgery, abdominal sacrocolpopexy is gaining popularity as the technique of choice for the management of pelvic organ prolapse. However, laparoscopic surgery is more at risk of complications, especially in the elderly and obese[1]. In this study, we will analyze a cohort of patients undergoing minimally-invasive sacrocolpopexy to see whether increased age and BMI would lead to more morbidity, and a higher recurrence rate.
Study design, materials and methods
A single-center retrospective study was conducted at our university hospital, between 2003 and 2021. This study was approved by the Ethics Review Committee of our institution and all patients had signed an informed consent form.
Patients who underwent mesh laparoscopic sacrocolopopexy between January 2003 and December 2021 were included in the cohort. A standardized surgical technique was performed by two different surgeons experienced in urogynecological surgery: an anterior-posterior double arm sacrocolpopexy using a polypropylene monofilament mesh. The mesh used were Pro-swing® - Textile Hi-Tec™, Fr and PRO-Swing® PS4 – Balmer Medical, Fr.
Before surgery, all patients underwent a thorough clinical examination to assess pelvic organ prolapse (POP,) which was reported according to Baden Walker classification. Patients who were diagnosed with stress urinary incontinence (SUI), on physical exam (full bladder cough test after prolapse reduction), were offered the option to have a simultaneous trans-obturator sling (TOT).
The following parameters were collected for each patient: age, BMI, parity, and grade of prolapse. Operative data collection included associated procedures performed (adhesiolysis, SUI surgery), operative time, conversion rate, estimated blood loss, perioperative injuries (urinary, digestive, or vascular injuries) and length of hospital stay (LOS). Postoperative follow-up was scheduled systematically for all patients at five weeks, six months and yearly thereafter. Surgical success was assessed by gynecological examination at each follow-up visit. Data on early (voiding difficulties, delayed mobility, wound complications, febrile morbidity, postoperative ileus, thromboembolic phenomena) and late postoperative complications (prosthesis-related, dyschezia, constipation, dyspareunia) were collected, as well as the rates of POP relapse and the occurrence of de novo SUI.
The distribution of age and BMI was considered parametric based on the histogram distribution and Q-Q plots, therefore, parametric tests were used for this study. To determine the appropriate threshold for age and BMI according to postoperative complications, a ROC analysis was performed. The AUC (area under the curve) was very low to establish the age and BMI cut-offs. Accordingly, the median was used as a cutoff, and patients were divided into age and BMI groups, using thresholds of 65 years and 25 Kg/m2, respectively.
Operative and postoperative parameters were compared between the age and BMI groups, using the ki2 test or the student's test for qualitative or quantitative data, respectively. The level of significance was set at 5%.
Results
A total of 170 patients were included in the study. Demographic parameters are reported in Table 1.
Most of the patients (70%) had grade 3 POP compared to 6% and 22% for grade 2 and grade 4, respectively. 25% underwent concomitant TOT placement for documented SUI.
Blood loss was estimated for all patients less than 200 ml, and transfusion was never necessary. Adhesiolysis was necessary in 9% of the cases. Patients with adhesiolysis did not require a longer hospital stay (p=0.3). Operative time, length of hospital stay, and duration of follow-up are reported in Table 1.
3 patients (1.8%) had intraoperative incidents with no need to convert in any of the patients:
- Vesical breach sutured with 3-0 vicryl. The Foley catheter was left in place and removed after 7 days.
- Utero-ovarian bleeding and hematoma that led to hemostatic right adnexectomy.
- Suspicion of a rectal serosa lesion, closed with reinforced 2-0 vicryl sutures and verification of etancheity with rectal insufflation.
During follow-up, patients complaining of bulging sensation, sexual, urinary or bowel dysfunction were examined, and overall satisfaction was assessed. Anatomical recurrence was assessed by the Valsalva maneuver on pelvic gynecologic exam, and no prolapse recurrence was detected at follow-up.
The rate of de novo SUI that required TOT reoperation was 4%. The overall rate of complications was estimated at 11% (including early and late postoperative complications).
Prosthesis related complications consisted in vaginal exposure of the implant and was diagnosed in 4 patients (2%): 2 patients were classified as 2A T4 S1, and the other 2 as 2B T4 S1 (discharge)[2].
Differences according to age (<65 and ≥65 years) and BMI (<25 and ≥25 kg/m2), between operative time, hospital stay, and rate of complications are reported in Table 2. No statistical differences were found for all parameters between the groups.
Interpretation of results
In this study, we compared the surgical outcomes of laparoscopic sacrocolpopexy according to BMI and age.
Our results did not show significant differences in terms of operating time between the normal weight and the overweight group. Furthermore, obese patients in our series were not at increased risk of operative injuries and postoperative complications. Conversion to laparotomy was not an issue in our series (0 cases), and this was attributed to the performance of an open laparoscopic technique (using the umbilical stalk), with uterine and sigmoid suspension that facilitates exposure throughout the procedure. Furthermore, the patients were operated by highly experienced surgeons, which explains why operating times, conversion rates, injuries, and therefore early complications were not affected by the BMI of the patient.
When considering the age of patients, since mesh sacrocolpopexy is the recommended procedure for younger women, operating elderly patients using the same technique seems feasible if the complication rates are comparable between the two groups.
In our series, we have demonstrated the safety of mesh sacrocolpopexy in operable elderly patients, without an increase in the risk of early postoperative complications and LOS. It has previously been thought that age is a predictor of complications in the postoperative period, especially when surgery is expected to be complex and lengthy, such as minimally-invasive sacrocolpopexy.[3] However, when surgery is performed in centers with a high urogynecological workload and with experienced hands, the safety of the procedure is maintained.
The short-term complications that followed this procedure are minor ones.
- Vesical breach: Vesical dissection can be very tricky in unexperienced hands, especially with severe cystoceles. Fortunately, small breaches can be efficiently repaired laparoscopically, and the mesh can be inserted, nonetheless.
- Rectal serosa breach: Although rectal injuries counter-indicate mesh insertion due to contamination of the operative field, we only had a suspicion of serosal breach, therefore, we proceeded with mesh insertion.
In practice, age and BMI should not be regarded as an obstacle to sacrocolpopexy anymore. Surgeons with common laparoscopic practice should be at ease performing this procedure to correct severe prolapses. Moreover, this study showed no specific problems related to the use of prosthesis for the prolapse correction, even on the long term (mean follow-up interval of 6 years).
Concluding message
This study showed that mesh sacrocolpopexy is associated with high success rates, good functional results, and low rates of surgical complications, when performed by experienced surgeons, even in patients with BMI over 25 and age over 65. These results should be reassuring for clinicians treating overweight, and elderly patients presenting for POP. Also, based on these results, there is no clear morbidity associated with the use of prosthesis for reduction of urogenital prolapse, even on the long term.